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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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spin-chem ld-l reagent SMITH KLINE DIAGNOSTICS, INC. k812472 09/14/1981
spirotel MIR MEDICAL INTL. RESEARCH SRL k043528 07/19/2005
spline dental implant system SULZER CALCITEK, INC. k010073 01/19/2001
spor-o-therm MDT CORP., INC. k801462 07/28/1980
st.jude medical mediguide enabled livewire steerable electrophysiology catheter, livewire electrophysiology catheter, response electrophysiology catheter with lumen, response electrophysiology catheter and sjm epicardial catheter system, supreme electrophysiology catheter St. Jude Medical k151622 07/15/2015
stackhouse smoke evacuator, models st-3000, st 3100 STACKHOUSE, INC. k001082 06/15/2000
standard wheelchair platform DESIGN SPECIFIC LTD k073565 02/06/2009
starlight, model pd9012 F.P. RUBINSTEIN Y CIA S.R.L. k073317 09/03/2008
stat ultra violet liquid BECKMAN INSTRUMENTS, INC. k781432 10/03/1978
staxx fx system SPINE WAVE, INC. k053336 07/03/2006

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